Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on document review, and interview with laboratory personnel, the laboratory failed to follow establish written procedures for patient slide labeling requirements on two of four cases reviewed on the day of survey. Findings are as follows: 1. The laboratory performs Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by the Mohs Histotechnician (M-HT) during a tour of the laboratory at 8:40 a.m. on November 17, 2023. 2. The Dermatology General Mohs Procedures policy, included the following criteria for labeling of patient slides under section 6: A. Slide labels printed from EPIC contain the following: 1) Surgical number 2) Specimen ID and block sub number 3) Patient name 4) Date 5) Task performed (ex. Stain name) 6) Sanford Bemidji 3. Two of the four cases reviewed on the day of survey had patient slides that were hand labeled. The hand labeled slides were missing many of the six elements required for labeling a slide as found in the procedure. Patient # 23M0069M, performed on 03/30/2023, the three patient slides were labeled with the case #, block and sub number. The three patient slides were missing the surgical number, patient name, date, task performed, and location (Sanford Bemidji) Patient # 23M00220M, performed on 11/01/2023, the three patient slides were labeled with the case #, last name, first initial, and block and sub number. The three patient slides were missing the surgical number, date, task performed, and location (Sanford Bemidji) 4. In an interview on November 17, 2023 at 10:05 a.m., the M-HT confirmed the above findings. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to document the time patient specimens were received into the laboratory for 2022 and 2023. Findings are as follows: 1. The laboratory performs Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by the Mohs Histotechnician (M-HT) during a tour of the laboratory at 8:40 a.m. on November 17, 2023. 2. In an interview during the tour of the laboratory at 8:45 a.m. on November 17, 2023, M-HT confirmed the time each specimen is received into the laboratory is not documented on the Mohs map or elsewhere. She confirmed, in the past there had been a spot on the Mohs map for this to get documented, however the Mohs map had been edited over time and the time of specimen receipt is no longer getting captured. 3. Requirements for documentation of patient specimen (tissue) receipt time into the laboratory were not found in the Dermatology General Mohs Procedures manual. 4. The time of tissue receipt into the laboratory was not documented in testing records for four of four cases reviewed on date of survey. See below: Patient identifier # Date of test # of Stages EXXXX320 07/21/2022 2 EXXXX939 10/07/2022 1 EXXXX256 03/30/2023 1 EXXXX633 11/01/2023 1 5. In an interview on November 17, 2023 at 10:00 a.m., the M-HT confirmed the above findings. The laboratory performs Mohs on approximately 350 patients annually. The number of patient tissue samples (stages) varies with each patient. -- 2 of 2 --